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IRCT20200305046700N10 IRCT 2025-11-02 Tehran University of Medical Sciences Investigating the effect of creatine supplementation on patient-reported functional outcomes after hip arthroplasty Investigating the effect of creatine supplementation on improving patient-reported functional outcomes after THA hip arthroplasty: A randomized, double-blind clinical trial 2025-08-11 anticipated 60 Recruiting https://irct.ir/trial/83969 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization and Allocation Concealment A 1:1 randomization sequence was generated using a random number generator in a statistical software program to assign participants to either the creatine supplement or placebo group. To maintain balance in group sizes, random block sizes of 4 and 6 were used. The final allocation sequence was generated and kept by an independent statistician who was not involved in participant recruitment or assessment. Participant allocation was implemented using sequentially numbered, sealed, opaque envelopes to ensure allocation concealment, so that individuals involved in participant enrollment and assessment had no prior knowledge of the randomization sequence or group assignments. Blinding The study was conducted in a double-blind manner (participant and assessor). Neither the participants nor the outcome assessors were aware of the assigned interventions (creatine or placebo). The supplement and placebo were identical in appearance, packaging, and labeling. Only the research pharmacist, who had access to the randomization code, was authorized to break the code in emergency situations. Any code breaks were documented and will be reported in the final study report, Blinding description: In this study, the patient and their clinical caregiver are specifically blinded. One group receives standard postoperative medications plus a creatine-like placebo for 6 weeks, and the other group receives 5 grams of creatine supplement daily for 6 weeks after surgery in addition to standard medications (cephalexin, acetaminophen, and NSAIDs). 3 Hip Osteoarthritis. Intervention 1: Intervention group: In addition to the usual medications (cephalexin, acetaminophen, and NSAIDs), this group received creatine supplement powder (manufactured by Karen Company) at a dose of 5 grams once a day for 6 weeks (42 days) after surgery. Intervention 2: Control group: This group receives 5 grams of placebo powder (manufactured by Karen Company) daily, along with standard medications (cephalexin, acetaminophen, and NSAIDs), for 6 weeks after surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no decision yet
public Dr. Mohammadreza Razzaghof
No.17, Sheybani Alley, North Jamalzadeh Street
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 0196 m.razzaghof@gmail.com Tehran University of Medical Sciences scientific Mohammadreza Razzaghof
No.17, Sheybani Alley, North Jamalzadeh Street
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 0196 m.razzaghof@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) People aged 45 to 75 Both sexes (male and female) Candidate for primary unilateral total hip replacement Ability to follow up for follow-up visits 45 years 75 years Both Any previous history of hip surgery Severe endocrine disorders A history of cardiovascular, hepatic, hematological, respiratory, or peripheral vascular disease A history of kidney disease or CKD with a GFR less than 30 mL/min Active cancer A history of use of corticosteroids or anabolic steroids in the past 2 weeks M16 Osteoarthritis of hip Treatment - Drugs Placebo Intervention group: In addition to the usual medications (cephalexin, acetaminophen, and NSAIDs), this group received creatine supplement powder (manufactured by Karen Company) at a dose of 5 grams once a day for 6 weeks (42 days) after surgery. Control group: This group receives 5 grams of placebo powder (manufactured by Karen Company) daily, along with standard medications (cephalexin, acetaminophen, and NSAIDs), for 6 weeks after surgery. Hip Abductor muscles volume. Timepoint: before intervention, 1 month post intervention, 3 months post intervention. Method of measurement: Ultrasonography. Knee Extensor muscles volume. Timepoint: before intervention, 1 month post intervention, 3 months post intervention. Method of measurement: Ultrasonography. Tehran University of Medical Sciences Tehran University of Medical Sciences Tehran University of Medical Sciences Approved 2025-05-20 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Central building, Office of Vice-President for Research Affairs, Keshavarz Blvd., Tehran , Iran. Tehran Tehran Iran (Islamic Republic of)